Guidance Document for Describing Non-Guideline In Vitro Test Methods

The purpose of this guidance is to harmonise the way non-guideline in vitro methods
are described and thereby facilitate an assessment of the relevance of test methods
for biological activities and responses of interest, and an assessment of the quality
of data produced, irrespective of whether these tests are based on manual protocols
or assay protocols adapted for use on automated platforms or high-throughput screening
systems (HTS). This guidance outlines the elements considered relevant for providing
a comprehensive description of an in vitro method to facilitate the interpretation
of results and support scientifically defensible fit-for-purpose applications.